Commercial stage pharmaceutical company Shield Therapeutics announced on Friday that it has received final minutes from the US Food and Drug Administration (FDA) of its recent pre-New Drug Application (NDA) submission meeting.
The AIM-traded firm said those minutes formed the official record of the meeting with the FDA, and had provided it with the necessary guidance to progress submission of an NDA for Feraccru without conducting additional pivotal clinical trials.
It said the NDA would be submitted as soon as possible in 2018, and the work would be funded within the company's current cash resources.
On 16 March, the company had provided an update on the AEGIS-CKD Phase III study following detailed analyses of the data from the double-blind period of this study of Feraccru.
At the same time, Shield also confirmed it had met with the FDA for a previously-scheduled pre-NDA submission meeting.
In that meeting, Shield shared the data and findings from all available analyses of the AEGIS-CKD Phase III trial, including key safety and efficacy parameters.
Based on the minutes of the meeting provided to the company by the FDA and Shield's own review of the data, the company said it now intended to finalise and submit an NDA for Feraccru as soon as possible.
"As I said at the time, we were surprised and disappointed by the initially reported top-line findings of the AEGIS-CKD study, as Feraccru had previously consistently demonstrated positive efficacy and safety, which facilitated its approval in Europe and where it has continued to gain commercial traction," said CEO Carl Sterritt.
"The discussions with and feedback received from FDA, together with our own review of the AEGIS-CKD data, provides us with the confidence to submit Feraccru's NDA as soon as possible and without conducting additional pivotal trials.
"If approved, the NDA would permit this novel product to be marketed in the world's most important pharmaceutical market."
Sterritt said the US geographic expansion the company hoped the positive data would facilitate would "hugely increase" Feraccru's commercial opportunity, further increasing the attractiveness of an asset that already had broad approval in Europe and gold standard composition of matter protection through 2035 in the two most important pharmaceutical markets in the world.
"At the same time, we are encouraged by the level of interest shown in the initial stages of our European partnering activities for Feraccru and we will continue to diligently work towards finalising a suitable agreement at the earliest opportunity."